Masivet

RSS

masitinib mesylate

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 26/09/2013

Authorisation details

Product details
Name
Masivet
Agency product number
EMEA/V/C/000128
Active substance
masitinib mesylate
International non-proprietary name (INN) or common name
masitinib mesylate
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QL01XE90
Publication details
Marketing-authorisation holder
AB Science S.A.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
17/11/2008
Contact address
3 avenue George V
75008 Paris
France

Product information

24/09/2013 Masivet - EMEA/V/C/000128 - R/0016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

Treatment of non-resectable dog mast-cell tumours (grade 2 or 3) with confirmed mutated c-KIT tyrosine-kinase receptor.

Assessment history

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